Abstract
Purpose The goal of this study was to compare the efficacy and safety of fixed-dose combinations of amlodipine/losartan potassium/chlorthalidone (A/L/C) and A/L in Korean patients with stage 2 hypertension inadequately controlled by A/L. Methods This study was an 8-week, randomized double-blind, multicenter, phase III clinical trial. Three hundred forty volunteer patients with stage 2 hypertension were randomized to receive A/L/C or A/L. The primary end point was a change in sitting systolic blood pressure (SitSBP) after 8 weeks of treatment. As secondary end points, the change in SitSBP after 2 weeks of treatment and the change in sitting diastolic blood pressure (SitDBP) were compared between treatment groups. All patients were assessed for adverse events, clinical laboratory data, and vital signs. Findings Of 330 patients from 33 medical centers, 328 patients who had available efficacy data were analyzed. After 8 weeks of double-blind treatment, the mean (SD) changes in SitSBP at 8 weeks were −16.4 (0.9) mm Hg and −6.9 (1.0) mm Hg in the A/L/C and A/L groups, respectively. A/L/C had a statistically superior blood pressure–lowering effect compared with that of A/L (mean [SD] difference, 9.5 [1.3] mm Hg; P < 0.001). The mean (SD) change in SitDBP at 8 weeks was significantly greater with A/L/C (−8.0 [0.6] mm Hg) than with A/L (−3.6 [0.6] mm Hg) (P <.001). In terms of the mean (SD) change in SitDBP at 2 weeks compared with baseline, A/L/C (−5.9 [0.5] mm Hg) was statistically different from A/L (−2.9 [0.5] mm Hg) (P <.001). Mean (SD) SitSBP change from baseline to week 2 was −13.2 (0.9) and −5.5 (0.9) in the A/L/C and A/L groups, respectively, with a statistically significant blood pressure–lowering effect (P < 0.001). The number of participants who achieved target blood pressure at week 8 was significantly higher in the A/L/C group (93 patients [55.7%]) than in the A/L group (48 [29.8%]) (P < 0.001). Adverse drug reactions were observed in 23 patients (7.0%), and the incidence of dizziness was significantly higher in the A/L/C group than in the A/L group (4.8% vs 0.6%, P = 0.037) There were no serious adverse events associated with the study drugs. Implications The results of this study suggest that A/L/C had a significantly increased blood pressure–lowering efficacy compared with that of A/L and had a good safety profile. ClinicalTrials.gov identifier: NCT02916602.
| Original language | English |
|---|---|
| Pages (from-to) | 2049-2060 |
| Number of pages | 12 |
| Journal | Clinical Therapeutics |
| Volume | 39 |
| Issue number | 10 |
| DOIs | |
| Publication status | Published - 2017 Oct |
Fingerprint
All Science Journal Classification (ASJC) codes
- Pharmacology
- Pharmacology (medical)
Cite this
}
Comparison of Fixed-dose Combinations of Amlodipine/Losartan Potassium/Chlorthalidone and Amlodipine/Losartan Potassium in Patients With Stage 2 Hypertension Inadequately Controlled With Amlodipine/Losartan Potassium : A Randomized, Double-blind, Multicenter, Phase III Study. / Hong, Soon Jun; Jeong, Han Saem; Han, Seung Hwan; Chang, Ki Yuk; Hong, Bum Kee; Lee, Bong Ki; Chae, Shung Chull; Kim, Woo Shik; Park, Chang Gyu; Heo, Jung Ho; Lee, Seung Uk; Kim, Young Dae; Kim, Kee Sik; Choi, Jung Hyun; Kang, Hyun Jae; Kim, Jae Joong; Kang, Seok Min; Choi, Young Jin; Shin, Joon Han; Chun, Kook Jin; Shin, Dong Gu; Park, Seong Hoon; Kwan, Jun; Choi, Yu Jeong; Jeong, Myung Ho; Chae, Jei Keon; Kim, Dong Woon; Cho, Jung Rae; Han, Kyoo Rok; Won, Kyung Heon; Park, Sang Ho; Lee, Sang Kon; Kim, Sang Hoon; Jung, Jina; Kim, Cheol Ho.
In: Clinical Therapeutics, Vol. 39, No. 10, 10.2017, p. 2049-2060.Research output: Contribution to journal › Article
TY - JOUR
T1 - Comparison of Fixed-dose Combinations of Amlodipine/Losartan Potassium/Chlorthalidone and Amlodipine/Losartan Potassium in Patients With Stage 2 Hypertension Inadequately Controlled With Amlodipine/Losartan Potassium
T2 - A Randomized, Double-blind, Multicenter, Phase III Study
AU - Hong, Soon Jun
AU - Jeong, Han Saem
AU - Han, Seung Hwan
AU - Chang, Ki Yuk
AU - Hong, Bum Kee
AU - Lee, Bong Ki
AU - Chae, Shung Chull
AU - Kim, Woo Shik
AU - Park, Chang Gyu
AU - Heo, Jung Ho
AU - Lee, Seung Uk
AU - Kim, Young Dae
AU - Kim, Kee Sik
AU - Choi, Jung Hyun
AU - Kang, Hyun Jae
AU - Kim, Jae Joong
AU - Kang, Seok Min
AU - Choi, Young Jin
AU - Shin, Joon Han
AU - Chun, Kook Jin
AU - Shin, Dong Gu
AU - Park, Seong Hoon
AU - Kwan, Jun
AU - Choi, Yu Jeong
AU - Jeong, Myung Ho
AU - Chae, Jei Keon
AU - Kim, Dong Woon
AU - Cho, Jung Rae
AU - Han, Kyoo Rok
AU - Won, Kyung Heon
AU - Park, Sang Ho
AU - Lee, Sang Kon
AU - Kim, Sang Hoon
AU - Jung, Jina
AU - Kim, Cheol Ho
PY - 2017/10
Y1 - 2017/10
N2 - Purpose The goal of this study was to compare the efficacy and safety of fixed-dose combinations of amlodipine/losartan potassium/chlorthalidone (A/L/C) and A/L in Korean patients with stage 2 hypertension inadequately controlled by A/L. Methods This study was an 8-week, randomized double-blind, multicenter, phase III clinical trial. Three hundred forty volunteer patients with stage 2 hypertension were randomized to receive A/L/C or A/L. The primary end point was a change in sitting systolic blood pressure (SitSBP) after 8 weeks of treatment. As secondary end points, the change in SitSBP after 2 weeks of treatment and the change in sitting diastolic blood pressure (SitDBP) were compared between treatment groups. All patients were assessed for adverse events, clinical laboratory data, and vital signs. Findings Of 330 patients from 33 medical centers, 328 patients who had available efficacy data were analyzed. After 8 weeks of double-blind treatment, the mean (SD) changes in SitSBP at 8 weeks were −16.4 (0.9) mm Hg and −6.9 (1.0) mm Hg in the A/L/C and A/L groups, respectively. A/L/C had a statistically superior blood pressure–lowering effect compared with that of A/L (mean [SD] difference, 9.5 [1.3] mm Hg; P < 0.001). The mean (SD) change in SitDBP at 8 weeks was significantly greater with A/L/C (−8.0 [0.6] mm Hg) than with A/L (−3.6 [0.6] mm Hg) (P <.001). In terms of the mean (SD) change in SitDBP at 2 weeks compared with baseline, A/L/C (−5.9 [0.5] mm Hg) was statistically different from A/L (−2.9 [0.5] mm Hg) (P <.001). Mean (SD) SitSBP change from baseline to week 2 was −13.2 (0.9) and −5.5 (0.9) in the A/L/C and A/L groups, respectively, with a statistically significant blood pressure–lowering effect (P < 0.001). The number of participants who achieved target blood pressure at week 8 was significantly higher in the A/L/C group (93 patients [55.7%]) than in the A/L group (48 [29.8%]) (P < 0.001). Adverse drug reactions were observed in 23 patients (7.0%), and the incidence of dizziness was significantly higher in the A/L/C group than in the A/L group (4.8% vs 0.6%, P = 0.037) There were no serious adverse events associated with the study drugs. Implications The results of this study suggest that A/L/C had a significantly increased blood pressure–lowering efficacy compared with that of A/L and had a good safety profile. ClinicalTrials.gov identifier: NCT02916602.
AB - Purpose The goal of this study was to compare the efficacy and safety of fixed-dose combinations of amlodipine/losartan potassium/chlorthalidone (A/L/C) and A/L in Korean patients with stage 2 hypertension inadequately controlled by A/L. Methods This study was an 8-week, randomized double-blind, multicenter, phase III clinical trial. Three hundred forty volunteer patients with stage 2 hypertension were randomized to receive A/L/C or A/L. The primary end point was a change in sitting systolic blood pressure (SitSBP) after 8 weeks of treatment. As secondary end points, the change in SitSBP after 2 weeks of treatment and the change in sitting diastolic blood pressure (SitDBP) were compared between treatment groups. All patients were assessed for adverse events, clinical laboratory data, and vital signs. Findings Of 330 patients from 33 medical centers, 328 patients who had available efficacy data were analyzed. After 8 weeks of double-blind treatment, the mean (SD) changes in SitSBP at 8 weeks were −16.4 (0.9) mm Hg and −6.9 (1.0) mm Hg in the A/L/C and A/L groups, respectively. A/L/C had a statistically superior blood pressure–lowering effect compared with that of A/L (mean [SD] difference, 9.5 [1.3] mm Hg; P < 0.001). The mean (SD) change in SitDBP at 8 weeks was significantly greater with A/L/C (−8.0 [0.6] mm Hg) than with A/L (−3.6 [0.6] mm Hg) (P <.001). In terms of the mean (SD) change in SitDBP at 2 weeks compared with baseline, A/L/C (−5.9 [0.5] mm Hg) was statistically different from A/L (−2.9 [0.5] mm Hg) (P <.001). Mean (SD) SitSBP change from baseline to week 2 was −13.2 (0.9) and −5.5 (0.9) in the A/L/C and A/L groups, respectively, with a statistically significant blood pressure–lowering effect (P < 0.001). The number of participants who achieved target blood pressure at week 8 was significantly higher in the A/L/C group (93 patients [55.7%]) than in the A/L group (48 [29.8%]) (P < 0.001). Adverse drug reactions were observed in 23 patients (7.0%), and the incidence of dizziness was significantly higher in the A/L/C group than in the A/L group (4.8% vs 0.6%, P = 0.037) There were no serious adverse events associated with the study drugs. Implications The results of this study suggest that A/L/C had a significantly increased blood pressure–lowering efficacy compared with that of A/L and had a good safety profile. ClinicalTrials.gov identifier: NCT02916602.
UR - http://www.scopus.com/inward/record.url?scp=85029596842&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85029596842&partnerID=8YFLogxK
U2 - 10.1016/j.clinthera.2017.08.013
DO - 10.1016/j.clinthera.2017.08.013
M3 - Article
C2 - 28939406
AN - SCOPUS:85029596842
VL - 39
SP - 2049
EP - 2060
JO - Clinical Therapeutics
JF - Clinical Therapeutics
SN - 0149-2918
IS - 10
ER -